Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
REGULATORY
ONODERA GT’s Parkinson’s Gene Therapy Gets Sakigake Tag
Japan’s Ministry of Health, Labor and Welfare (MHLW) on June 8 granted sakigake designation to ONODERA GT Pharma’s gene therapy candidate GT0003X for the treatment of Parkinson’s disease.GT0003X was selected for the fast-track program based on its novel mechanism of…
To read the full story
Related Article
- Oncolys’ Telomelysin Wins Backing from Japan Panel
May 22, 2026
- ONODERA GT Pharma Targets 2026 Filings for Two Gene Therapies
February 19, 2026
REGULATORY
- MHLW Lifts Olanzapine Diabetes Contraindication for Antiemetic Use
August 26, 2026
- PMDA Flags Severe Gastritis, Esophagitis with Checkpoint Inhibitors
August 26, 2026
- Japan Grants Sakigake Tag to NS-035, MSA-01
August 26, 2026
- Japan Approves Takeda’s Orzeyful, Insmed’s Brinsupri and More Drugs
August 25, 2026
- Keytruda SC Heads to Japan Approval, Ipsen’s Ojemda for Conditional Nod
August 25, 2026
More than a year after Dupixent (dupilumab) became the first antibody therapy approved for COPD in Japan, drug makers are…
A few weeks ago, I had coffee with a very talented executive. Let’s call him Kenji. He has a great job, a big salary, and a solid team. But he was unhappy. He felt bored and wanted a new challenge.…
Japan’s Central Social Insurance Medical Council (Chuikyo) on November 5 approved the reimbursement listing for a slate of new medicines,…
The Japanese government on March 7 announced new NHI prices to be applied in the FY2025 drug price revision, revealing…
The Japanese government approved a bill to amend the Pharmaceuticals and Medical Devices (PMD) Act at its Cabinet meeting on…
Japan’s health ministry doled out regulatory approvals for a throng of new medicines on December 27 including Eli Lilly’s obesity…
Japan’s all-important reimbursement policy panel on December 20 approved an outline of drug pricing reforms for FY2024, which enshrines a…